Feb

2014

Neuro Kinetics Normative Data Template CD Cl II

Company:Neuro Kinetics, Inc.
Date of Enforcement Report:2/19/2014
Class lI:

PRODUCT

Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
Recall Number Z-0966-2014

REASON
The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process..

RECALLING FIRM/MANUFACTURER
Neuro Kinetics, Inc., Pittsburgh, PA on 11/21/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
148

DISTRIBUTION
Nationwide and Canada

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Neuro Kinetics Normative Data Template CD Cl II

Amy Sellers

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